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EC number: 231-203-4 | CAS number: 7446-26-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 Jan 2017-01 Feb 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
- Version / remarks:
- Adopted 7 Sep 2009
- Deviations:
- yes
- Remarks:
- 2 males and 4 females were dosed. GSD out of range. Relative humidity of test material out of range. Temperature/RH in animal room sporadically out of range. No impact on the study results.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Entitad Nacional de Acreditaciόn, Madrid, Spain
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Dizinc pyrophosphate
- EC Number:
- 231-203-4
- EC Name:
- Dizinc pyrophosphate
- Cas Number:
- 7446-26-6
- Molecular formula:
- H4O7P2.2Zn
- IUPAC Name:
- dizinc(2+) (phosphonooxy)phosphonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Other: white, odourless
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Specific Pathogen Free
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, C/Argenters 7, Local AB, 08290 Cerdanyola del Vallés, Barcelona, Spain
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks
- Weight at study initiation: 261.9-273.5 g (males) and 196.0-217.5 g (females)
- Fasting period before study: not specified
- Housing: group housed 3-4 per cage with Capsumlab Lecho_10 (autoclavable) bedding, and enrichment devices (nesting material, tubes, and chew blocks)
- Diet: Global diet 2914C, Harlan Teklad, Station Road, Blackthorn, Bicester, Oxon, OX25 1TP, UK, ad libitum
- Water: tap water in water bottles, ad libitum
- Acclimation period: at least 7 days, with 90 min to the nose-only restraining tubes on the day of exposure
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 1.5
- Humidity (%): 20-43
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 17 Jan 2017 To: 01 Feb 2017
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- clean air
- Mass median aerodynamic diameter (MMAD):
- ca. 2.37 µm
- Geometric standard deviation (GSD):
- ca. 6.71
- Remark on MMAD/GSD:
- MMAD during exposure was 2.37 μm (average of three particle size determinations). This value is within the respirable range (1-4 μm) and appropriate for acute inhalation toxicity testing. GSD was above the upper limit of 3 in the second and third particle size determinations, indicating that the particle size distribution of the aerosol generated throughout the 4-hour exposure period was not homogeneous. Nevertheless, at the highest concentration of test material technically achievable (4.73 mg/L, gravimetric determination) the mean percentage of particles below the upper limit of 4 μm, over the whole exposure period, was 66% (79%, 67% and 52.5% for particle size determinations #1, 2 and 3, respectively), and this value was considered acceptable.
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: flow-past, nose-only exposure chamber made of anodised aluminium
- Exposure chamber volume: approximately 3 L
- Method of holding animals in test chamber: rats were individually exposed in glass tubes matching their size, positioned radially around the exposure chamber
- Source and rate of air: clean air with a flow rate at each exposure tube of approximately 1 L/min
- Method of conditioning air: filtered air from a compressor
- System of generating particulates/aerosols: a dust aerosol was generated from the desiccated test material using a rotating brush aerosol generator (RBG 2000, PALAS GmbH, Germany) and conveyed via glass tubing from the generator to the exposure chamber; aerosol concentration was determined by gravimetric analysis.
- Method of particle size determination: MMAD and the GSD were determined on results from a PIXE cascade impactor, using Microsoft Excel® software (Microsoft Corporation, USA).
- Treatment of exhaust air: not specified
- Temperature, humidity, pressure in air chamber: Temperature and relative humidity in the chamber were measured continuously during exposure using a thermohygrometer (Kimoth110, Kimo). The target range for temperature was 19-25 °C, the target range for relative humidity (RH) was 30-70%. The exposure airflow rate was adjusted using the pressure difference over a Venturi tube. Target flow range was 0.5-1.0 L/min through each inhalation tube.
TEST ATMOSPHERE
- Brief description of analytical method used: Three gravimetric measurements were taken during exposure to measure exposure concentration. The sampling flow was similar to the air flow rate per exposure port. Test aerosol samples were collected for 2 min periods onto a Whatman filter (grade F319-04) using a filter sampling device. The filters were weighed before and immediately after sampling using a calibrated balance. The gravimetric aerosol concentration was calculated from the amount of test material present on the filter and the sample volume.
- Samples taken from breathing zone: yes
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: Determined gravimetrically three times during the exposure. The cumulative particle size distribution of the test aerosol was determined using a PIXE cascade impactor, measured by gravimetric analysis of the test material deposited on each stage of the cascade impactor.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): MMAD and GSD were calculated on the basis of results from the impactor using Microsoft Excel® software (Microsoft Corporation, USA). Target ranges were 1 to 4 µm for the MMAD, and 1.5 to 3 for the GSD.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: Exposure concentration was the highest technically achievable concentration (4.73 mg/L) - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetric
- Duration of exposure:
- ca. 4 h
- Concentrations:
- 5 mg/L (nominal)
4.73 mg/L (analytical) - No. of animals per sex per dose:
- 2 males and 4 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: hourly during exposure (only grossly abnormal signs), immediately and 1 h after exposure, and once daily thereafter until the end of the observation period. All animals were observed for a period of 14 days after administration. All animals were weighed on the day of treatment just before starting exposure (study day 1), on study days 2, 4, 8 and immediately before sacrifice on study day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: histopathology - Statistics:
- No statistical analysis was required.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 4.73 mg/L air (analytical)
- Based on:
- test mat.
- Remarks:
- gravimetric aerosol concentration
- Exp. duration:
- 4 h
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: Chromorrhinorrhea and breathing difficulty was observed in all six animals immediately following exposure and five of six at one hour thereafter. Chromodacryorrhea was observed in five of six animals immediately following exposure and at one hour thereaf
- Body weight:
- A decrease in mean body weight of approximately 9.5% in males and 1% in females was observed between study day 1 (exposure) and study day 2. From study day 2 to the end of the observation period (day 15), body weight increased gradually in all animals.
- Gross pathology:
- Red lungs with red spots were observed in one male and red spots were also present in the lungs of two females. These findings were considered to be related to test item exposure. No macroscopic changes were observed in any of the rest of the organs/tissues.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- The LC50 of dizinc pyrophosphate was greater than 4.73 mg/L air (gravimetric aerosol concentration), and based on the GHS classification criteria, can be considered unclassified.
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